Tuesday, March 11, 2014

FDA Draft Guidance Extends Reprint Policy To Medical Reference Texts, Clinical Practice Guidelines

FDA Draft Guidance Extends Reprint Policy To Medical Reference Texts, Clinical Practice Guidelines-thegraysheet: FDA is revising its policy on the procedures that device companies should follow when they distribute journal articles and other publications that discuss unapproved uses of legally marketed products to health care providers. The new draft document is not much different from the agency’s 2009 final guidance on good reprint practices, but includes new sections on how these practices apply to medical reference texts and clinical practice guidelines.